Personal Genome Service Receives FDA Warning

Silver Spring, MD—The U.S. Food and Drug Administration (FDA) recently issued a warning letter to 23andMe, a genetic testing service, for marketing its product for the diagnosis of diseases without approval.

23andMe’s DNA Spit Kit is a Personal Genome Service (PGS) device that, according to the company’s Web site, analyzes over 240 health conditions and traits, including risk for breast cancer and diabetes. It also reports on how the patient’s genetic makeup indicates they would respond to certain medications and drugs. As FDA’s warning letter indicates, some of these intended uses have not been classified and their lack of premarket approval are thus in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).

In the letter, Alberto Gutierrez, director at the Center for Devices and Radiological Health, expressed concern over potential health risks that could result from false positive or negative results of the PGS testing, including “morbidity-inducing actions.” This kind of personal genetic testing could also sway participants to either start or stop taking supplements, which could affect them positively or negatively.

Despite numerous interactions with 23andMe, including 14 meetings and “hundreds of email exchanges,” the company has failed to assure FDA that the PGS’s intended uses are “analytically or clinically validated;” the letter indicates that 23andMe even went on to launch new television marketing campaigns without FDA approval. FDA concluded with an order for 23andMe to immediately discontinue marketing the PGS device until FDA provides marketing authorization.

PGS is just one example of the trend for personalized health analysis. Several companies are offering personalized nutrition products, which could influence shoppers’ supplement purchases. One such company, Michigan-based Health Enhancement Products Inc., recently developed a personal health assessment called The Wellness Profile. Introduced in August 2013, the urinalysis test gauges oxidative stress and antioxidant capacity in the participant, providing a better understanding of his or her overall health and fitness level. Such knowledge could point to which supplements may help them achieve better health.